Atorvastatin as Adjunctive Therapy in COVID-19

COVID-19 Clinical Trial

— STATCO19  

Official title:

Prospective Randomized Open-label Trial of Atorvastatin as Adjunctive Treatment of COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04380402
• Other study ID #: MountAuburn
• Status: Recruiting
• Phase: Phase 2
• Start date: June 25, 2020
• Est. completion date: May 8, 2022

Study information

• Verified date: March 2021
• Source: Mount Auburn Hospital
• Contact: Lin H Chen, MD
• Phone: 617-499-5026
• Email: lchen[@]mah.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.

Description:

COVID-19 is caused by SARS-CoV-2, a β-coronavirus that binds to the zinc peptidase angiotensin-converting enzyme 2 (ACE2). No drug is licensed to treat COVID-19, but adjunctive pharmacologic interventions have been proposed for their immunomodulatory effects, including statins. About 5% of cases are considered critical, with severe respiratory failure as well as myocarditis, and thromboses, and are associated with high fatality rate. Statins affect endothelial dysfunction and have anti-inflammatory and immunomodulatory effects.

This prospective, randomized, open-label trial of atorvastatin as adjunctive treatment of COVID-19 in hospitalized patients aims to study:

1. Will atorvastatin reduce progression to severe or critical COVID-19 disease and death compared to standard care?

2. Will atorvastatin lead to improved clinical outcome of COVID-19 disease at 30 days compared to standard care?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 8, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient aged 18-85 years, admitted with suspected COVID-19 disease based on clinical criteria (typical upper respiratory symptoms, e.g. runny nose, sore throat, dry cough, associated with COVID-19 infection).

Exclusion Criteria:

• already on chronic statin therapy, known hypersensitivity or adverse events to statins, negative nasopharyngeal (NP) swab for SARS-CoV-2, pregnancy and lactation, need for ICU admission, ALT or AST >2X upper limit of normal; CPK > 5x upper limit of normal; and creatinine clearance <50%, chronic treatment with colchicine, cyclosporin, digoxin, fusidic acid, azole antifungals, niacin.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Atorvastatin
Atorvastatin 40 mg tablet

Locations

Country	Name	City	State
United States	Mount Auburn Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mount Auburn Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Fedson DS, Opal SM, Rordam OM. Hiding in Plain Sight: an Approach to Treating Patients with Severe COVID-19 Infection. mBio. 2020 Mar 20;11(2). pii: e00398-20. doi: 10.1128/mBio.00398-20. — View Citation

Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System: A Review. JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286. Review. — View Citation

Parihar SP, Guler R, Brombacher F. Statins: a viable candidate for host-directed therapy against infectious diseases. Nat Rev Immunol. 2019 Feb;19(2):104-117. doi: 10.1038/s41577-018-0094-3. Review. — View Citation

Vandermeer ML, Thomas AR, Kamimoto L, Reingold A, Gershman K, Meek J, Farley MM, Ryan P, Lynfield R, Baumbach J, Schaffner W, Bennett N, Zansky S. Association between use of statins and mortality among patients hospitalized with laboratory-confirmed influenza virus infections: a multistate study. J Infect Dis. 2012 Jan 1;205(1):13-9. doi: 10.1093/infdis/jir695. Epub 2011 Dec 13. — View Citation

Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 29;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death	Proportion of patients in each arm that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death, as described by WHO Ordinal Scale for Clinical Improvement scores 5-8 with higher being worse.	30 days
Secondary	Overall score of patients in each arm on Day 7 based on WHO Ordinal Scale for Clinical Improvement	Description of clinical status of patients in each arm based on WHO Ordinal Scale of Clinical Improvement on Day 7, scores 1-8 with higher being worse.	7 days
Secondary	Overall score of patients in each arm on Day 30 based on WHO Ordinal Scale for Clinical Improvement	Description of clinical status of patients in each arm based on WHO Ordinal Scale of Clinical Improvement on Day 30, scores 1-8 with higher being worse.	30 days
Secondary	Proportions of patients in each arm who test negative for SARS-CoV-2 on Day 7	Proportions of patients in each arm who are tested on Day 7 and have negative PCR	7 days

External Links

•   Statin therapy in acute influenza